The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.

FDA Holds Workshop on Orphan Drugs

Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.

Company and People Notes: Pfizer Completes King Tender Offer; Cook Pharmica Names VP of R&D and CSO; and More

Follow-ons were all the rage at this year's JP Morgan Healthcare Conference.

The Novartis Foundation for Sustainable Development held a symposium in December 2010 to continue dialogue on how the private and public sector can work together in achieving the UN Millennium Development Goals.

Government and private sector efforts take on counterfeit drugs online.

As biologic-drug patents move toward expiration in the US, Indian firms with experience in the follow-on biologics arena are eager to partner with global manufacturers and secure their place in the growing biosimilars market.

Legislation has hampered cross-border drug importation and limited choice.

Taking care to note, file and re-check information can save one from future mishaps.

One year following the earthquake in Haiti, the pharmaceutical industry and private sector participate in efforts for long-term relief.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Novartis is looking to advance its personalized medicine treatment programs by entering into a definitive agreement to acquire Genoptix, a laboratory offering personalized diagnostic services, for approximately $470 million or $25 per share.

The European Medicines Agency (EMA) has initiated a safety review of Sanofi's anti-arrhythmic medicine Multaq following reports of serious liver injury in patients.

Novartis Acquires Genoptix; Lilly Exec Becomes Savient CEO; and More.

Reflecting the manufacturing restructuring ongoing in the bio/pharmaceutical industry, Amgen and sanofi-aventis announced the sale of manufacturing facilities to contract manufacturers.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

Johnson & Johnson's run of quality issues, recalls and other bad news continues with yet another product recall.

Merck Teams with Parexel; Roche CFO to Retire; and More

Last Friday, French daily Le Figaro reported that sanofi-aventis intended to reach an acquisition agreement with Genzyme that would value the latter company at roughly $76 per share, or a total of $20 billion.

FDA Sets Limits for Acetaminophen in Prescription Combination Products

The EU Commission is on the lookout for "potentially problematic patent settlements" and has asked several pharma companies to submit copies of their patent settlement agreements made between originator and generic companies.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

GlaxoSmithKline is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

An industry expert answers a reader's question about using a volumetric dry-material feeder and jet mill to create a finished product.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

With counterfeit medicines increasingly appearing in legitimate supply chains and even in the clinical stages of product development, a recent white paper has outlined practical steps that may help companies address the issue of counterfeits and diverted products.